Evaluation of a Personalized Physical Activity Coaching Program in Parkinson's Disease (APA-PARK)

There is growing interest for physical activity in Parkinson's disease in order to improve mobility and function of these patients. It seems from previous studies that difficulty, intensity and specificity of physical exercises are important parameters conditioning the effect of physical activity on cerebral plasticity and clinical improvement.

Thus, the aim of this study is to evaluate the benefits of a Personalized Physical Activity coaching program, including scheduled and frequent follow up associated with progressive readaptation of exercise intensity depending on individual performances (during 3 months), versus free practice of physical activity in Parkinson's disease.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Behavioral: Personalized Physical Activity coaching program; Behavioral: Free practice of physical activity

Detailed Description

Type of study: a randomized, single-blind, parallel-group, controlled clinical trial.

Number of centers: 1 (Clermont-Ferrand)

Patients

Patients eligible for inclusion will be randomized to one of the two groups:

• APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)
• APA- : patients will do free practice of physical activity during 3 months.

Study Performance Patients will be evaluated 3 times : at J0 (baseline, V1), 3 months after Personalized Physical Activity coaching program (J0+3M, V2), and 3 months after the end of the Personalized Physical Activity coaching program (J0+6M)

V1:

• Signature of an informed consent form.
• Demographic and clinical characteristics (sex, age, disease duration, treatments).

V1, V2, V3

• Neurological evaluation (Unified Parkinson Disease Rating Scale part III score)
• Evaluation of quality of life (Parkinson's Disease Questionnaire 39-item version (PDQ-39), participation to Daily life activities (Lawton and Brody Activities of Daily Living scale (IADL questionnaire25)
• Evaluation of performances for specific tests for balance (stabilometry), muscular strength (isometry)
• Evaluation of cardiorespiratory function (VO2pic et 6 min Walk Test)
• Evaluation of body composition (lean body mass/fat mass) with DEXA.
• Dropout rates at V2 and V3
• Evaluation of the activity with the eMOUVE application in a subgroup of patients.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • Chu Clermont-Ferrand
    • Principal Investigator: Anna Marques

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical criteria for Parkinson's disease
• Men or women aged from 18 to 80 years old.
• Social security coverage.
• Ability to provide informed consent.

Exclusion Criteria:

• neurological disease other than Parkinson's disease
• severe depression (Beck Depression Inventory>37) or psychiatric comorbidities (UPDRS I )
• significant cognitive impairment (MoCA<24)
• orthopedic impairment with functional restriction
• contraindication to physical exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APA+; APA + : patients will beneficiate of Personalized Physical Activity coaching program during 3 months (1 hour, twice by week, during 3 months)	Behavioral: Personalized Physical Activity coaching program
Other: APA-; APA- : patients will do free practice of physical activity during 3 months.	Behavioral: Free practice of physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of the Unified Parkinson Disease Rating Scale part III score	at +3months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline of Parkinson's Disease Questionnaire 39-item version score	at +3months
Change from baseline of the Lawton and Brody Activities of Daily Living scale score	at +3months
Change from baseline of the percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application	at +3months
Change from baseline of percentage of sedentarity, mild, moderate and intense activity using the eMOUVE application	at + 6 months
Change from baseline of balancing abilities measured by stabilometry	at +3months
Change from baseline of balancing abilities measured by stabilometry	at + 6 months
Change from baseline of muscular strength measured with isometric test	at +3months
Change from baseline of muscular strength measured with isometric test	at +6months
Change from baseline of VO2pic	at +3months
Change from baseline of VO2pic	at + 6 months
Change from baseline of the 6 min Walking Test score	at +3 months
Change from baseline of the 6 min Walking Test score	at + 6 months
Change from baseline of fat and lean body mass measured by DEXA	at +3 months.
Change from baseline fat and lean body mass measured by DEXA	at +6 months.
dropout rates	at +3 months
dropout rates	at +6 months

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques; UFR STAPS

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: June 3, 2016
• First Submitted That Met QC Criteria: June 27, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 27, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Physical activity; Physical exercise; Parkinson's disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CHU-0265; 2016-A00040-51 (Registry Identifier: 2016-A00040-51)